The impact of the modified Baveno classification on key patient groups

Q: What do you expect the implications of the updated Baveno classification to be on people with mild to moderate OSA, who are asymptomatic or have no comorbidities?

Prof. Randerath: The modified Baveno classification provides a nice level of freedom for the physician and the patient to decide a path together. In the yellow portion of the scheme that denotes a moderate risk, a choice to begin therapy can be made if the symptoms are in the foreground. But, if symptoms are not as severe, the physician and patient may agree to revisit the situation some months or even a year down the road. This allows time to see if respiratory events change in any way, either in terms of frequency or nature. So, overall, the criteria provide both an immediate treatment path and a follow-up path. It is actually a beautiful way of bringing the patient into the decision as well.

Q: How might this more personalized approach impact a patient’s chance of success on therapy?

Prof. Randerath: The modified Baveno classification is all about more accurate patient identification, either through cardiovascular risk, symptomology or a combination thereof. In turn, if you more accurately identify patients in need of treatment, you are more likely to identify patients who will experience the full benefits of treatment. Additionally, the path to convincing a patient to do something about their breathing problems during sleep is easier when the data supporting the need to treat is clearer.

I am convinced that patients who are treated according to the scheme achieve higher adherence. And, data from the preliminary studies based on the first scheme and the retrospective study based on the modified scheme show that, if we treat the right patients, we also have a positive effect on symptoms and blood pressure as a parameter for cardiovascular risk.

Q: What, if any, patient groups that have previously been treated per other criteria may not be treated per the modified Baveno classification? What could be the impact on this group/these groups?

Dr. Randerath: Yes, first, those who are in the green group will not be treated. These are people who have less than 30 respiratory events, who have no symptoms and who have a low cardiovascular risk, but some of them are treated today. For example, a patient with 20 events per hour will be treated almost anywhere in the world, regardless of symptomology or risk factors. But we have no evidence that this patient offers a prognostic advantage and, since the patient is less symptomatic, they may also be unwilling to use therapy.

We have a high drop-out rate here, much higher than in other groups. The modified classification gives the physician a means to say, “OK, we know there's something going on, but it’s not urgent. We'll keep an eye on you, we'll do follow-up examinations, but for now we don't have to treat you.” Many patients in this situation will be grateful.

Then we have the patients in the yellow group, where we see moderate cardiovascular risk or symptoms. We do not yet have a clear prognostic indication here. We don't have to recommend the patient get immediate treatment, because of their actual cardiovascular risk but we allow the physician and patient to decide together whether they initiate treatment or re-evaluate at a later time.

There will be people who say, “I want to keep my risk as low as possible, I'll go for the treatment.” Others will say, “No thank you, I don’t want to or will not go on therapy.”

But, for patients in the red zone, we have a clear message: “Even if you have fewer respiratory events, you still have a high cardiovascular risk, and therefore you should begin therapy promptly to reduce your risk.”

Q: Conversely, what patient groups have not previously been treated per other criteria but that should be per the modified Baveno classification?

Prof. Randerath: Patients with an AHI below 30 but with high cardiovascular risk would be recommended for immediate therapy by the modified Baveno classification. For those patients in the yellow group, there is the freedom to opt for treatment or not, at least per the modified Baveno classification.

We hope to demonstrate that in patients with an AHI below 30 or even 15 but with a high cardiovascular risk, we can improve blood pressure as a target parameter as we were able to show in the retrospective studies. If we can show this, then we have a strong argument for treatment.

Q: We know the symptom profile of OSA for women often varies from that of men. How might the modified Baveno classification account for women and their different symptom profile?

Prof. Randerath: Yes, the European Society of Cardiology (ESC) guidelines, which cover the SCORE schemes, also include gender, so women are included. However, women have a lower cardiovascular risk than men. That means they would fall into a different risk group and would be included in this way. And when it comes to symptoms, it’s important that we don't just focus on sleepiness. The classic sleep apnea man is overweight, over 60, snores and is sleepy.

That's not how many women with OSA present. For them, sleepiness is often not the issue, but rather disturbed sleep or feeling exhausted as well as fatigued. They could be recommended for treatment per the modified Baveno classification because these criteria are also recorded.

Typically, they have a lower AHI and would fall into the green category. But of course, they also have a lower cardiovascular risk, to be honest. But, of course, treatment options would be available based on the symptoms. Not necessarily prognostic, but symptomatic.

Q: Could you go into more detail on how age is taken into account, specifically regarding the SCORE2 and SCORE2(OP) thresholds in different age groups to define cardiovascular risk levels 1-3 for the modified Baveno classification?

Dr. Randerath: Yes, we actually adhered very closely to the ESC guidelines, which also take age into account. It's true that for younger people, even a lower risk SCORE leads to a higher risk, because it increases the risk over the long term.

So, we deliberately did not create an age subgroup, nor did we create a gender subgroup, because they are included in these SCORES. We wanted to stick to established scores and keep the scheme as simple as possible, meaning we didn't include additional variables. However, in this way, an older patient is included via the SCORE2(OP) and the SCORE Diabetes is also included, so we can cover as many people as possible.